Looking Deeper Into AdvaMed's Code Of Ethics

Dear Mr. Van Haute,

I read with great interest your recent online-exclusive article for Podiatry Today entitled “Why Your Sales Rep Doesn’t Bring You Flowers Anymore” (see http://www.podiatrytoday.com/why-your-sales-rep-doesn%E2%80%99t-bring-yo... ). Although I thank you for taking the time to write this feature, I can’t help but feel that there were some significant omissions as to the exact intentions of AdvaMed’s intentions. You do not really address the Code of Ethics and what the “Sunshine Law” truly reflects to the industry AdvaMed represents.

First and foremost, to better understand what many of us deal with, virtually on a daily basis, with the industry reps you consider such a vital part of the industry/doctor relationship, please read my blog at http://www.podiatrytoday.com/blogged/open-letter-salespeople-who-visit-m... .

Although we all deal with excellent reps in our time and I’m happy to say that a very few I’ve dealt with have been truly exceptional, my blog was the culmination of 11 years of frustration in dealing with your industry. I will also agree with your assertion there is a critical misunderstanding of the relationship between doctors and the industry you represent. Where would your industry be without the physicians who make themselves available to you for products they believe in? Now I feel we are being attacked and sanctioned because of it.

The tone of your article implies that physicians don’t look out for their patients’ best interests and there was a necessity for the AdvaMed Code of Ethics to control how rampant the problem has become. You also mention “AdvaMed … strongly encourages (emphasis mine) both industry and physicians to commit to openness and highly ethics standards in the conduct of their business interactions." I’m not so sure that enforcing a “Code of Ethics” and enacting laws that speak to this implies a strong encouragement. It is now written in stone. Rather than say “strongly encourages,” perhaps “requires” may define the relationship a little better.

Insights On Using New Products In The Hospital Setting

Let’s run through a scenario that happens more often than not. An industry rep tells us of a new screw/plate/implant/anchor available. We would like to use this new technology in the hospital setting and ask the rep to bring this new device to our surgical case. The rep calls us back and tells us that the hospital needs us to call and request the device in person. We do this and the tirade of “Why can’t just use what’s on the shelf?” ensues.

After arguing the matter for 30 minutes, the equipment manager of the operating room relents and agrees to allow the device in the OR for a one-time use. Happily, the case goes smoothly and the device and the rep do wonderfully well. Everyone is happy, except the hospital. We then get more angry phone calls that the hospital just lost a pile of money on this new device.

Regardless of the rampage, we are so happy with the device, we call the rep and tell him or her that we would like to continue to use the product. The rep then calls us back and tells us that in order to get the product “through the system,” we have to fill out a bunch of paperwork. The paperwork takes us about an hour to complete but in the interest of the patient, we go through with it anyway. Sometimes we even have to appear before a hospital committee and fight to get the product into the hospitals. This takes time away from our office and is a rather frustrating endeavor. We do it anyway because we believe in the product and think our patients will do better with this new screw/plate/implant/anchor.

You need us to do this for you. Without donating our time to you for this, how would your products get into the marketplace?

That is what is so insulting about your assertion that “if you think the sales reps should show up at your podiatry practice with pizza or doughnuts for your entire office staff to compensate for the time it takes to showcase the latest innovations, or you expect a bouquet of flowers to mark the occasion, you are going down the wrong path.”

I’m sorry to say, Mr. Van Haute, but it is your industry that is going down the wrong path. Based on your above comments in quotations, you are not acutely or accurately aware of what exactly physicians do for your industry. We donate our time to help you. Yes, we take solace in the fact that your products help our patients but ultimately, the billion-dollar industry that you represent does very little in that guise to help us as physicians.

Let’s look at your comment from a cultural perspective. Your reps are coming to our place of business. In my experience, many rarely give notice, are generally not as informed as they should be because many just don’t get the training they really need to be excellent at their jobs, and also tend to be very demanding of our time. They are generally doing this during our busy office hours when our patients are our most important focus of attention. Due to these reasons, many of my medical colleagues absolutely refuse to see reps at all. They are ultimately uninvited guests in our homes.

In some cultures, even as an invited guest, if you show up with no “gift,” the host politely asks you to leave. When growing up, my parents instilled this in me. If invited to dine at a friend’s house, a small show of appreciation is in order. Show up on time (in Japan, actually being five minutes late is appropriate) and well dressed with your most polite manners in order and a small token of thanks.

So during busy office hours, how are we to welcome an uninvited “guest” who is sometimes borderline rude to our staff and demanding of our attention while we're trying to make a living? Physicians work harder and have to see more patients now to make less money. I anticipate it will only get worse before it gets better for us. This is not about influence, Mr. Van Haute. It’s about respect, courtesy and etiquette.

Does your industry honestly believe, and is it trying to lead the public to believe, that by bringing us a box of doughnuts or pens with a company logo on it, it will make such a huge difference that we would jeopardize our trusted doctor/patient relationship?

That being said, there have been many instances we have all heard of, of companies spending small fortunes on doctors and sending them to the Bahamas, on golf excursions, etc. I have been in practice for 11 years now and can honestly say those days are long gone for the most part, especially for the profession I hold so dear. Also, if you dig deeper, Mr. Van Haute, you will see that your industry pushed this much more so than the physicians were asking for it. Indeed, I am sure that pulling the plug on these tokens of gratitude would have hurt some feelings but making sure it is now something that is legally reprehensible is another matter altogether.

To add insult to injury, you say “The AdvaMed Code’s chief goal is to ensure that decisions relating to medical treatments are always based on the best interest of the patient” as if to say that it wasn’t in the past and solely because of your Code of Ethics, patients should now rest easy because you have arrived to ensure their proper care.

Transparency And Disclosure

AdvaMed’s efforts to enact the “Sunshine Law” call for transparency in the financial matters between physicians and your constituents, but there are many issues with this. A 2009 New York Times article expressed concern about this law only affecting doctors but not others who are involved in decision making for patient care.1 None other than Congressman Pete Stark (D-Calif.) raised this concern. Stark is the originator of the “Stark Law,” the groundbreaking anti-kickback legislation that we all know so well. In his eyes, the major issue with “Sunshine” is that if it only targets doctors (which it does right now), the law can leave loopholes that will let companies “give rebates to outpatient clinics to favor certain medical products over others.” Congressman Stark also goes on to add, “It has become an amazing subculture in the medical system as to how to get kickbacks.”

The same article talks about how “the rules in any final health care legislation may not be comprehensive or ironclad enough to create meaningful disclosure.”1 Does the “Sunshine Law” take into account any other medium that factors into the global interest of the patient or does it only target physicians? Congress discussed a proposed overhaul before the “Sunshine Law” passed to include disclosure by pharmacists, biomedical researchers, professional medical associations and health insurers. How is that effort going? As of right now, the only people under scrutiny are the physicians. Why aren’t others under the same scrutiny, including those associated with AdvaMed?

Stephen J. Ubl, the current President and CEO of AdvaMed, got his start in Washington working with Senator Charles E. Grassley (R-Iowa.).2 Senator Grassley was the one who originally introduced the “sunshine” bill in 2007. A May 22, 2008 letter sent by Ubl to Sen. Grassley and then-Sen. Herb Kohl (D-Wis.) extolled the “Physician Payment Sunshine Act” and gave the senators AdvaMed’s support (see Appendix A below the references). Mr. Ubl was recognized as a top association lobbyist by the Capitol Hill newspaper The Hill in its annual list of top lobbyists in May of 2007.2

For the sake of transparency, how much does AdvaMed spend on helping with campaigns in Washington? I’m sure the public is equally as interested in this as they are in how many pizzas the industry feeds doctors.

Who hired AdvaMed to do this job? I asked some of my patients and they have no idea what AdvaMed is. The people you say you are trying to protect don’t even know about you. I would very much like the opportunity to sit down with the AdvaMed Board of Directors and ask them this very question.

Shining A Light On The Medical Device Tax And Efforts To Repeal It

In 2007, the federal government starting looking at several “device makers” as they were described in the aforementioned New York Times article and forced them to disclose how much they paid orthopedic surgeons to use a certain brand of hip and knee replacement implants.1 Within one year, the total payments to doctors by these companies dropped by $167 million. It doesn’t say anywhere who got paid, whether these doctors still used the same implants, whether they got paid or not, the efficacy of those implants versus the others used and whether those payments actually did influence those doctors one way or the other. Maybe I’m being naïve to a certain degree but where did that extra $167 million go?

Perhaps most of it went to mount an effort to repeal the 2.3 percent medical device tax.3-6 Since 2008, the medical industry has spent $150 million on lobbying against this tax, according to the Washington Post.5 This tax on the industry was meant to raise $29 billion over ten years to make healthcare more affordable to the masses.5

This tax only affects device manufacturers yet Mr. Ubl applauds the bipartisan support AdvaMed is getting in repealing the tax by saying: “Patients, the health care system and the American economy are winners when legislators work together like this.”4

I just don’t get it. How exactly is repealing this tax going to help the patients?

Editors at Bloomberg.com challenged the claims AdvaMed made against this tax and what it would do to the industry it protects, including the assertion that the tax would harm innovation and force the medical technology industry to move their operations overseas.6

It’s also no wonder that those that support the repeal on this tax come from states where AdvaMed’s industry has a very strong foothold and where campaign contributions are high.7 States like Utah, Minnesota and Massachusetts are the top three. I wonder if the campaign funding would suddenly disappear if they didn’t fight for your cause. Is that transparent enough?

Raising Questions About Patient Advocacy

In regard to patient advocacy, what has AdvaMed actually done in this arena other than reprimand physicians for eating pizza and getting flowers delivered? In my view AdvaMed is not a patient advocacy group yet it dangles that carrot in front for all to see. The Food and Drug Administration (FDA) is trying to increase how much scrutiny medical devices undergo before being approved for use in the United States. AdvaMed is advocating less stringent guidelines as to the FDA approval process.3 If the FDA doesn’t have to look so hard, it won’t cost these companies as much money to create and process trials for device approval and their products get into the marketplace faster.

How is this protecting the consumer? Will less FDA scrutiny protect the public?

“The Heart of the Matter: How Congress and Special Interests Kept Crucial Clinical Data Secret” outlines how AdvaMed was involved in changing legislation to make sure some details of certain studies never came to light.9 Mr. Van Haute, how was AdvaMed protecting patients when it lobbied for Congress to change crucial portions of a bill that stopped the public and their physicians from learning why certain FDA trials were terminated? The original bill forced the trial data to be disclosed after termination, the actual study subjects from learning such things as what exactly surgeons implanted in them, and gave physicians the opportunity to improve upon the issue that caused the trial to be terminated. According to the aforementioned "Heart of the Matter" report, after your constituents become involved, the bill was changed so that no disclosure on these matters was even possible.9

What information is in there that the industry feels isn’t crucial for doctors and patients? When you take a look at the change in this bill, which AdvaMed advocates, it turns out these important additions came at the eleventh hour, and those reviewing the changes only had one hour to rule on whether to implement the changes or not. If you care to review the article available online, there is much more to the story.9 I encourage you to explain how these changes within the bill were in the best interest of the public.

I wonder what AdvaMed’s opinions are on tort reform. What could have a bigger impact on the medical health system, its costs and patient quality of care than that? What does AdvaMed say about how the American people pay more for prescription drugs than any populace in the world?10 Are your constituents working with your counterparts at the Pharmaceutical Research and Manufacturers of America (PhRMA) to come to a more patient friendly solution? Where is the patient advocacy now? This is the epitome of how lobbyists isolate their goals in one arena and ignore it in another. It’s okay to point the finger at doctors and tell us we’ve had too many free lunches. If indeed you are a patient advocate, then why haven’t there been any other initiatives to expand your scope?

If this finger pointing continues, who is going to help evaluate, assess and use new technological advances? Why should we when we are so unfairly scrutinized? You want us to get your products in the hospitals. You want us to donate our time to do this for you. You say that if you feed my staff, it will show an unfair bias toward certain products. You have the power of lobbyists behind you and we are struggling to make a living. Then you insult us and tell us that you are the ones looking out for the patients’ well being, plainly insinuating that we don’t. There is no symbiosis in this relationship.

Are we really bankrupting your industry by pizza delivery?

References

1. Singer N. Health bills aim a light on doctors’ conflicts. New York Times. Available at http://www.nytimes.com/2009/11/04/health/policy/04sunshine.html?pagewant... . Published Nov. 3, 2009. Accessed Nov. 25, 2013.

2. Available at http://www.inhealth.org/oth/Page.asp?PageID=OTH000050 . Accessed Nov. 25, 2013.

3. AdvaMed fights back against increased FDA scrutiny. Kaiser Health News. Available at http://www.kaiserhealthnews.org/daily-reports/2010/september/16/health-i... . Published Sept. 16, 2010. Accessed Nov. 25, 2013.

4. AdvaMed praises bipartisan efforts to repeal device tax. Available at http://advamed.org/news/13/advamed-praises-bipartisan-efforts-to-repeal-... . Published Feb. 6, 2013. Accessed Nov. 25, 2013.

5. Kliff S. How Obamacare’s medical device tax became a top repeal target. Washington Post. Available at http://www.washingtonpost.com/blogs/wonkblog/wp/2013/09/28/how-obamacare... . Published Sept. 28, 2013. Accessed Nov. 25, 2013.

6. Taxing medical devices will keep the US healthy. Bloomberg. Available at http://www.bloomberg.com/news/2012-06-06/taxing-medical-devices-will-kee... . Published June 6, 2012. Accessed Nov. 25, 2013.

7. Kirsch R. The house’s latest health care vote puts campaign cash ahead of people. The Next New Deal. Available at http://www.nextnewdeal.net/houses-latest-health-care-vote-puts-campaign-... . Published June 12, 2012. Accessed Nov. 25, 2013.

8. Available at http://advamed.org/news/78/new-study-device-use-does-not-drive-hospital-... . Published Oct. 28, 2013. Accessed Nov. 25, 2013.

9. Watzman N. The heart of the matter: how Congress and special interests kept crucial clinical data secret. Sunlight Foundation. Available at http://sunlightfoundation.com/tools/2009/heart_of_the_matter/ . Accessed Nov. 25, 2013.

10. Lutz A. See how much more Americans pay for prescription drugs. Business Insider. Available at http://www.businessinsider.com/see-how-much-more-americans-pay-for-presc... . Published Aug. 29, 2012. Accessed Nov. 29, 2013.



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